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Table 5Most Common Treatment-Emergent Adverse ReactionsIncidence in PMDD PlaceboControlled Clinical Trials.

Consideration should be given to changing the therapeutic regimenincluding possibly discontinuing the medicationin patients whose depression is persistently worseor who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidalityespecially if these symptoms are severeabrupt in onsetor were not part of the patient’s presenting symptoms.

Healthcare providers should inform patientstheir familiesand their caregivers about the benefits and risks associated with treatment with SARAFEM and should counsel them in its appropriate useHealthcare providers should instruct patientstheir familiesand their caregivers to read the Medication Guide and should assist them in understanding its contentsPatients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have.

SARAFEM has the potential to impair judgmentthinkingor motor skillsPatients should be cautioned about operating hazardous machineryincluding automobilesuntil they are reasonably certain that the drug treatment does not affect them adversely.

DUse in LIFE-THREATENING emergencies when no safer drug availablePositive evidence of human fetal risk.

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